FDA-Drug2024-07-03Class II
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Golden State Medical Supply Inc.
Hazard
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Sold states
Nationwide in the U.S.
Affected count
21,655 (30 count bottle), 34,149 (90 count bottle)
Manufactured in
5187 Camino Ruiz, Camarillo, CA, United States
Products
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0568-2024Don't want to check this manually?
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